Minerva Biotechnologies will soon start the first human trials testing its investigational therapy huMNC2-CAR44, a CAR T-cell immunotherapy intended for breast cancer that has spread to other parts of the body.
The announcement comes after the U.S. Food and Drug Administration (FDA) approved the company's investigational new drug (IND) application for the treatment, clearing it for clinical testing. The technology targets the protein MUC1*, associated with solid tumor cells. Minerva plans to start the first clinical studies before the end of 2019.
“We are delighted that we will soon be able to begin human clinical trials for metastatic breast cancer,” Cynthia Bamdad, Minerva's CEO, said in a press release.
“Over 95% of breast cancers are positive for MUC1*, and this cancer immunotherapy has the potential to bring hope to the many thousands of patients battling this terrible disease,” Bamdad added.
Chimeric antigen receptor (CAR) T-cells are a new approach to fighting cancer, which harnesses and strengthens the body's natural defenses to attack tumors. It involves collecting a patient’s own T-cells — immune cells which can directly kill targeted cells

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